Recruiting

tSCS

Sponsor:

Rahul Sachdeva

Code:

NCT07597161

Conditions

Spinal Cord Injuries (SCI)

Prediabetes / Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Transcutaneous Spinal Cord Stimulation (tSCS)

Sham transcutaneous spinal cord stimulation (tSCS)

Study Details

Brief summary:

This study evaluates the use of noninvasive transcutaneous spinal cord stimulation (tSCS) to improve glucose regulation and metabolic function in individuals with and without spinal cord injury (SCI) across a spectrum of metabolic states, including no diabetes, prediabetes, and type 2 diabetes (T2D).

Conditions

Spinal Cord Injuries (SCI)

Prediabetes / Type 2 Diabetes

Study ID

NCT07597161

Start date

Oct 20, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants must be at least 18 years of age and able to provide informed consent.

  • Chronic spinal cord injury (at least 1 year post-injury) with neurological level of injury T6 or above, classified as AIS A-D, or able-bodied individuals without a history of spinal cord injury or neurological disorder
  • Participants must meet criteria for normal glucose metabolism, prediabetes, or type 2 diabetes, determined using HbA1c, fasting plasma glucose, fasting insulin, or oral glucose tolerance testing (OGTT). Normal glucose metabolism is defined as HbA1c less than 5.7% and fasting plasma glucose less than or equal to 100 mg/dL. Impaired glucose metabolism (prediabetes or type 2 diabetes) will be identified by HbA1c greater than or equal to 5.7%, fasting plasma glucose greater than100 mg/dL (5.6 mmol/L), fasting insulin greater than 8.5-10 µIU/mL after at least 8 hours of fasting, or 2-hour plasma glucose greater than 140 mg/dL (7.8 mmol/L) during a standard OGTT performed using a 75 g anhydrous glucose load dissolved in water.
  • Participants taking diabetes medications may be included if their medication regimen has been stable for at least 12 weeks before enrollment. This ensures observed metabolic changes are attributable to tSCS rather than recent medication adjustments. Medication use will be documented and included as a covariate in analyses to account for potential effects

Exclusion Criteria:

  • Unstable medical conditions (e.g., cardiac disease, active infections).

  • Implanted devices (e.g., pacemakers, neurostimulators, ITB pumps).
  • Change of medications that alter glucose metabolism (e.g., corticosteroids).
  • Frequent, symptomatic hypoglycemia.
  • Inability to tolerate stimulation procedures or complete study protocols.
  • Diagnosis of Type 1 diabetes mellitus.
  • Skin breakdown, eczema, or other dermatological conditions (e.g., psoriasis) affecting the skin at the site of electrodes placement.
  • Females who are pregnant, breastfeeding, or intend to become pregnant.
  • Cognitive impairments, social/psychological problems, or other comorbid conditions that, in the opinion of the Investigator, will preclude them from participation.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active transcutaneous spinal cord stimulation

Individuals with and without spinal cord injury, including those without diabetes, with prediabetes, or with type 2 diabetes (T2D), for a total of six groups.

experimental: Sham tSCS

Individuals with and without spinal cord injury, including those without diabetes, with prediabetes, or with type 2 diabetes (T2D), for a total of six groups.

Interventions

Transcutaneous Spinal Cord Stimulation (tSCS)

Noninvasive Transcutaneous Spinal Cord Stimulation (tSCS)

Sham transcutaneous spinal cord stimulation (tSCS)

Inactive (sham) tSCS

Primary outcome measure

  • Glucose and Insulin Levels with Oral Glucose Tolerance Test (OGTT) [ Time Frame: Weeks 1, 2, 7, 13, and 19 ]

Central Contacts and Locations

Central contacts

Rahul Sachedva, PhD

859-257-4888rsa327@uky.edu

Vivek Pandey, PhD

8593233933vivek.pandey@uky.edu

Locations

Department of Physical Medicine and Rehabilitation-Research Suite

Recruiting

Lexington, Kentucky, United States, 40504

Contacts

Vivek Pandey, PhD

8593233933vivek.pandey@uky.edu

More Information

Sponsor

Rahul Sachdeva

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Spinal Cord Injury
  • Noninvasive Spinal Cord Stimulation
  • Type 2 Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Rahul Sachdeva on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.